MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC X-STOP INTERSPINOUS SPACER; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Catalog Number	1-2212
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Claudication (2550)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent treatment at l4/l5 levels.Post-operatively, the patient began to experience recurrence of neurogenic claudication.Diagnostic image studies revealed displacement of the spacer from the interlaminary space.As a result, a revision surgery was performed for removal followed by lumbar decompression and implantation of a new spacer.The alleged spacer was removed by loosening the locking screws on one of the wing clamps and removed in two pieces and reportedly intact.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: visual and functional inspection confirmed the left hook was separated from the spacer body.The left hook was threaded back into the spacer with no issues.Visual examination confirmed witness marks across the surface of the spacer.Root cause is undetermined.If information is provided in the future, a supplemental report will be issued.

• Brand Name: X-STOP INTERSPINOUS SPACER
• Common Device Name: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 7880043
• Report Number: 1030489-2018-01246
• Device Sequence Number: 2488624
• Product Code: NQO
• UDI-Device Identifier: 00643169132719
• UDI-Public: 00643169132719
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P040001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1-2212
• Device Lot Number: 2275781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 93